Endourology and Stones Do the Residual Fragments After Shock Wave Lithotripsy Affect the Quality of Life? Cahit Sahin, Murat Tuncer, Ozgur Yazıcı, Rahim Horuz, A. Cihangir C¸etinel, Bilal Eryıldırım, Fatih Tarhan, and Kemal Sarica OBJECTIVE PATIENTS AND METHODS

RESULTS

CONCLUSION

To evaluate the possible effects of residual fragments on the health-related quality of life in patients undergoing extracorporeal shockwave lithotripsy for renal stones. Seventy-one patients with residual fragments were divided into 2 further groups; group 1 (n ¼ 42; fragment size, 4 mm) and group 2 (n ¼ 29; fragment size, >4 mm). During 3-month follow-up, spontaneous passage rates; number of emergency department visits, amount of the analgesic required, additional procedures, and the changes in the quality of life were evaluated. Quality of life was evaluated using the Short Form 36 survey. Statistical analyses included independent sample t tests. Of the 42 cases with fragments 4 mm, although 92.8% patients passed the fragments spontaneously, fragments resided until 3 months in 4.8% patients. Again, after 2 sessions of extracorporeal shockwave lithotripsy, of the 29 cases with fragments >4 mm, 55% were stone free, whereas 14% still had residual fragments. Mean number of emergency department visit was found to be 0.07 and 0.5 in both groups, respectively. Mean analgesic need was 138.75 mg in group 1 and 375 mg in group 2. Although significantly lower scores were noted only for one parameter during 1-month evaluation in cases with larger fragments, they were present in all 8 parameters during 3-month evaluation. Larger residual fragments could significantly affect the quality of life. Emergency department visits and colic attacks are the causes of discomfort. Effective stone disintegration by an experienced urologist should be aimed to limit the negative effects of residual fragments on the quality of life. UROLOGY 84: 549e554, 2014.  2014 Published by Elsevier Inc.

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ith an increasing prevalence worldwide; urinary system stone disease represents a significant public health problem. The lifetime prevalence of the disease is 12% in men and 6% in women in the United States.1 As a common and serious problem,2,3 urolithiasis typically affects social life of the patients during their most active and productive stage, between 20 and 50 years.1 Concerning the stone-induced problems, in addition to pain, obstruction and recurrent infections, decreased productivity, loss of work time or employment, and although nowadays rare, renal failure are the welldocumented outcomes of recurrent urolithiasis.4 Taking these urolithiasis related bothersome symptoms into account, today little is known about the quality of Financial Disclosure: The authors declare that they have no relevant financial interests. From the Dr. Lutfi Kirdar Training and Research Hospital, Urology Clinic, Istanbul, Turkey; and the Faculty of Medicine, Urology Clinic, Medipol University, Istanbul, Turkey Reprint requests: Cahit Sahin, M.D., Ph.D., Dr. Lutfi Kirdar Training and Research Hospital, Urology Clinic, G€omec¸ sok. Sabancı-2 Sitesi A1 Kat 4 Daire 24 Acıbadem, _ Kadık€oy, 34718 Istanbul, Turkey. E-mail: [email protected] Submitted: December 23, 2013, accepted (with revisions): May 3, 2014

ª 2014 Published by Elsevier Inc.

life (QOL) of patients suffering from particularly recurrent urolithiasis, many of whom undergo multiple procedures as well as receive medical therapy during the course of the disease. With the help of minimally invasive procedures, namely extracorporeal shockwave lithotripsy (ESWL), ureteroscopy (flexible and semirigid) with intracorporeal lithotripsy (URS), and percutaneous nephrolithotripsy, most calculi can be removed in a safe and practical manner. However, each of these modalities is associated with some certain advantages and disadvantages where the choice of appropriate modality is, in most cases, based on stone and patient-related factors.5 Although such modalities may allow us to remove the stones in a safe and practical manner, the associated symptoms and morbidity induced particularly by the residual fragment (RF) remaining after these interventions make the stone disease a serious health problem with significant effects on patients’ QOL.2,3 Concerning the incidence as well as the clinical course of the RF after ESWL, although ESWL can make 90% of adults stone free,6 in their original study, Perks et al7 reported that of 111 cases 44 (40%) were stone free (SFR) and 40 (36%) http://dx.doi.org/10.1016/j.urology.2014.05.012 0090-4295/14

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had incomplete fragmentation with RF sizing >5 mm. In another study of 50 patients undergoing ESWL, 26 patients (52%) were SFR, 12 (24%) had clinically insignificant residual fragment (fragment size 4 mm) at 4 weeks after single session.8 Lastly, Osman et al9 evaluated 173 patients with RFs sized 4 mm after ESWL and noted that 21% of patients required retreatment for these fragments. QOL is an estimate of freedom from impairment, disability, or handicap.10,11 The concept of health-related QOL (HRQOL) is multidimensional and includes psychosocial, physical, and emotional status, as well as patient autonomy, and it is applicable to a wide variety of medical conditions.12 In an attempt to evaluate the life quality of the patients, both QOL and HRQOL tests have been used in different studies in an attempt to evaluate the changes in life quality of the individuals. Although both tests aim to evaluate the changes in QOL, HRQOL additionally aims to evaluate the impact of health problems on the life quality.12 To our knowledge, limited studies investigated the effect of RF on QOL in patients undergoing ESWL. Studies focusing on the QOL of stone formers are limited to those involving patient preferences on the treatment alternatives,13 stent placement,14 and QOL after ESWL or other surgical modalities.15,16 In this prospective study, we aimed to evaluate the possible effects of RF after ESWL on the QOL of the treated patients by using Short Form 36 (SF-36) questionnaire.

in the QOL have been well assessed in all cases. The impact of the RF after ESWL on QOL of the treated cases was evaluated from different aspects after 1 month and 3 months by administering the SF-36 questionnaire, which was filled in hospital conditions. All SF-36 surveys were administered to the referring patients in our department in an individual basis and they completed the survey by themselves in our department. To evaluate the QOL in our cases, we first compared the overall QOL scores in both subgroups with normal healthy volunteers in our country17 during 1- and 3-month evaluation period. The Medical Outcomes Study SF-36 survey Turkish version 1.018 was used to assess QOL. The SF-36 questionnaire consists of self-administered questions that quantify QOL using the following 8 multi-item scales: physical function (PF), role limitations because of physical health problems (RP), bodily pain (BP), general health perception (GH), vitality (VT), social function (SF), role limitations because of emotional problems (RE), and mental health.19 The 8 scales were scored separately from 0 to 100, with a higher score being indicative of a better result, and these scores were used for analyses of the comparisons among the groups. All analyses were performed by using NCSS 2007 and PASS 2008 statistical software programs. Concerning the SF-36 domains, the Student t test was used to compare the statistical significance of the differences between the patients in the present study and the normal healthy volunteers whose corresponding values were obtained from a previous study. The Mann-Whitney U test was used for the comparison of non-normally distributed parameters. The Yates continuity correction test and the Fisher exact test were used to analyze qualitative data. Statistical significance was considered as P >.01 and P 4 mm (n ¼ 29). When multiple residual calculi were present, the diameter of the largest RF is reported. After biochemical tests, plain abdominal radiography and sonography had been performed for radiologic evaluation. Noncontrast computed tomography was performed to determine the exact size of the RF when its presence was suspected. ESWL was performed by using an electromagnetic lithotripter (Dornier Compact Sigma, Dornier MedTech, Germany) with a maximum shock wave number of 3000 in each session at 120 kV values. A second session of ESWL was performed after a week if needed. The overall SFR status has been assessed at 3 months. All procedures have been performed by a single urologist in a single institution. During the follow-up period after ESWL, the spontaneous passage rate of the RFs, number of emergency department (ED) visits, the amount of the analgesic required (diclofenac sodium 75 mg intramuscularly at each referral), additional procedures for symptomatic and/or obstructing fragments, and the changes

Patient and Stone Characteristics A total of 71 cases with an average age of 41.32 years (range, 22-66 years) have been treated by ESWL for kidney stones. Male-to-female ratio was 3.7 (15 of 56). All stones were located in the renal pelvis, and the average stone size was 11.4 mm (10-25 mm). Of all 71 cases with residual RF after ESWL, 42 patients (59.2%) had RF sizing 4 mm and the remaining 29 cases (40.8%), however, had fragments sizing > 4 mm. Depending on the clinical course of the RFs, although fragments passed spontaneously in some cases, they stayed asymptomatic in some or became symptomatic and/or obstructive requiring additional procedures (repeat ESWL, double-J stent [DJ] or URS) in the remaining ones. Stone composition data were available for 50 patients. Stone analysis was done for 50 cases and revealed calcium oxalate monohydrate in 13 (25%), calcium oxalate dihydrate in 5 (10%), and mixed calcium stones in 32 (65%; mixed with hydroxylapatite and/or uric acid in different proportions; Table 1). Evaluation of our data in cases with RF revealed findings which have been described in the following sections.

550

Patients with RF £4 mm Of all 42 cases with RF sizing 4 mm, a total of 33 patients (79%) passed the fragments spontaneously during follow-up. Although in 25 patients (59.5%) the UROLOGY 84 (3), 2014

Table 1. Evaluation of the clinical course of RF after SWL in both groups Size of the Residual Fragment

Age, y Gender Male, n (%) Female, n (%) Stone size, mm Stone density, HU Mean size of RF, mm Clinical follow-up data after first ESWL session Spontaneous passage, n (%) Without any symptom, n (%) Symptomatic cases requiring medical management, n (%) Mean size of RF passed spontaneously (mm) Patients with symptomatic RF requiring further intervention, n (%) Type of intervention: ESWL, n (%) URS, n (%) DJ, n (%) Mean size of RF in cases with persistent fragments, mm Asymptomatic residual fragments, n (%) Asymptomatic residual fragments, stone size, mm Overall SFR rate after 3 months, n (%)

4 mm (n ¼ 42) Mean  SD

>4 mm (n ¼ 29) Mean  SD

40.24  9.36

42.40  10.33

8 (19.0) 34 (81.0) 10.50  2.72 690.00  146.85 3.40  1.76

7 (24.1) 22 (75.9) 12.30  4.17 974.00  189.66 5.00  1.98

33 (79.0) 25/33 (76.0) 8/33 (24.0) 3.00  1.16 9/42 (21.4)

9/29 (31.0) 9/9 (100) 0 (0) 4.50  1.21 20/29 (69.0)

8 (19.0) 1 (2.0) 0 (0.0) 3.90  1.08 2 (4.8) 3.70  0.98 40 (95.2)

11 (38.0) 7 (24.0) 2 (7.0) 5.60  1.41 4 (14.0) 3.50  0.84 25 (86.0)

P .263* .825y .030*,* .001*,** .001*,** .001y,** .034y,* .001*,** .001y,** .135y .007z,** .163z .001*,** .374* .218z

DJ, Double-J stent; ESWL, extracorporeal shock wave lithotripsy; HU, Hounsfield units; RF, residual fragment; SD, standard deviation; SFR, stone free; SWL, shock wave lithotripsy. *P 4 mm; 40%), 9 patients (31%) passed these fragments spontaneously in an asymptomatic manner within a mean time period of UROLOGY 84 (3), 2014

3 weeks (1-4 weeks). In the remaining 20 patients (69%), however, the fragments did not pass spontaneously and became symptomatic and/or obstructive necessitating an additional intervention to make the patient SFR. The mean sizes of the fragments in these 2 subgroups were 4.5 mm (range, 4.1-5.2 mm) and 5.6 mm (range, 4.39.5 mm), respectively. Type of the intervention was ESWL in 11 patients (38%), URS in 7 patients (24%), and DJ insertion in 2 patients (6%). After ESWL, although 7 patients (28%) became SFR within a time period of 6 weeks (1-8 weeks), 4 patients did still have asymptomatic RFs (14%). Evaluation of the patients with RF >4 mm after 2 sessions of ESWL demonstrated that although 16 patients (55%) became completely SFR, 4 patients (14%) still had RF with a mean size of 3.5 mm (1.9-4.5 mm). Lastly, all 7 patients undergoing URS as well as the 2 patients (7%) with DJ stent insertion became completely SFR. Table 1 summarizes the course of RF sizing >4 mm. Analgesic Use and ED Visits Comparative evaluation of 2 groups with respect to analgesic use showed that the patients with RF >4 mm required a higher mean analgesic use (375 mg [0-600 mg]), whereas patients with RF sized 4 mm required relatively less analgesic use (138.75 mg [0-300 mg]). The same outcome was true for the mean number of ED visits where this value was 0.5 (0-2) in patients with larger fragments 551

100

Table 2. Mean analgesic requirement and ED visits in the symptomatic cases in both groups >4 mm

(n ¼ 42), n (%)

(n ¼ 29), n (%)

Analgesic requirement No 22 (52.4) 9 (31) Yes 20 (47.6) 20 (69) ED visit No 39 (92.9) 14 (48.3) Yes 3 (7.1) 15 (51.7) Mean analgesic 138.75  0.99 375  1.37 required, mg Mean no. of visits 0.07 (0-1) 0.55 (0-2)

P

#

#

#

#

#

#

#

60 40 20

.124*

0 GH

PF

RP

BP

VT

Normal Healthy Volunteers

.001*,* .001y,* .001y,*

ED, emergency department; no, number *P

Do the residual fragments after shock wave lithotripsy affect the quality of life?

To evaluate the possible effects of residual fragments on the health-related quality of life in patients undergoing extracorporeal shockwave lithotrip...
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